Effect of Complex Weight-reducing Interventions on Rhythm Control in Obese Subjects With Atrial Fibrillation
HOBIT-FS
1 other identifier
interventional
160
1 country
1
Brief Summary
Obesity is a well-established risk factor for the development of atrial fibrillation (AF), while the reduction of body weight was shown to reduce the risk of AF. However, little is known about the effect of different weight-reducing interventions on AF burden. The study will evaluate the effect of a complex program aimed at weight reduction on AF burden in subjects after catheter ablation for AF and at least 1st degree obesity. This will be investigated in randomized study design and compared with patients receiving standard care without specific obesity-related intervention. The weight loss program will consist of diet, lifestyle and exercise counselling and, in selected subjects, also bariatric surgery in order to achieve a sustained weight loss of \>10% of initial body weight. Secondary aims include identification of patient phenotypes with the most benefits from weight reduction as well as elucidation of potential pathomechanisms linking obesity and AF, with the main focus being on low-grade inflammation. The project will help to define the optimal weight-reducing regimen in AF and to tailor the interventions to individual patient needs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Sep 2020
Longer than P75 for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 10, 2020
CompletedStudy Start
First participant enrolled
September 21, 2020
CompletedFirst Posted
Study publicly available on registry
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedOctober 30, 2020
October 1, 2020
4.1 years
September 10, 2020
October 28, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Atrial fibrillation burden
Atrial fibrillation burden expressed as % of total monitoring time at final visit
18 months
Secondary Outcomes (6)
Number of AF episodes on 14-day Holter monitoring
18 months
Progressive reduction of AF burden between 12- and 18-month follow up visit
18 months
hsCRP
18 months
Epicardial adipose tissue volume
18 months
Concentration of atrial natriuretic peptide (ANP)
18 months
- +1 more secondary outcomes
Study Arms (2)
Interventional
EXPERIMENTALPhysician-lead complex program of weight-reducing interventions including education, diet counselling and regular physical activity aimed at achieving and maintaining a 10% reduction of baseline body weight. Bariatric surgery - sleeve gastrectomy in a subgroup of subjects with BMI \> 35 kg/m2, i.e. standard indication of bariatric surgery (patients with BMI \> 35 kg/m2 and a presence of metabolic or other complications).
Conservative
NO INTERVENTIONRoutine treatment of obesity
Interventions
A structured motivational and goal directed program will be used for weight reduction involving physicians, nutritionists, educators and physiotherapists. Initially, based on the input data provided by the patient an individual nutritional plan will be designed with the aim of reducing caloric intake by 10%. Low-intensity aerobic exercise for 30 min will be prescribed 3-times a week with the aim of increasing the frequency to 5-times a week and participants will be offered the possibility to participate in regular physiotherapist-lead group exercises. Patients will be required to maintain a diet and physical activity diary. Regular reviews will be scheduled every 3-6 months according to the actual weight loss.
Bariatric surgery will be performed based on actual medical indication and independently of patient's participation in the study. Sleeve gastrectomy was selected as the currently most frequent restrictive type of bariatric surgery with a proven efficacy on weight reduction, metabolic status and low-grade inflammation
Eligibility Criteria
You may qualify if:
- Paroxysmal or persistent AF scheduled for primary RF ablation
- BMI ≥30 kg/m2
- Age 18-70 years
- Informed consent to the study
You may not qualify if:
- Previous ablation for AF
- left ventricular ejection fraction \< 40%
- Left atrium diameter \> 55 mm
- Active thyroid disease
- Chronic kidney disease stage IV-V (eGFR \< 0.5 ml/s)
- Chronic liver disease
- Active malignancy
- Inability to comply with study procedures
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Martin Haluziklead
Study Sites (1)
Institute for Clinical and Experimental Medicine
Prague, 14021, Czechia
Related Publications (1)
Stolbova K, Novodvorsky P, Jakubikova I, Dvorakova I, Mraz M, Wichterle D, Kautzner J, Haluzik M. Effect of Complex Weight-Reducing Interventions on Rhythm Control in Obese Individuals with Atrial Fibrillation Following Catheter Ablation: A Study Protocol. Adv Ther. 2021 Apr;38(4):2007-2016. doi: 10.1007/s12325-021-01667-0. Epub 2021 Mar 12.
PMID: 33710588DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof. Martin Haluzik, DSc.
Study Record Dates
First Submitted
September 10, 2020
First Posted
September 23, 2020
Study Start
September 21, 2020
Primary Completion
October 31, 2024
Study Completion
June 30, 2025
Last Updated
October 30, 2020
Record last verified: 2020-10